BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 16769104 · Received April 19, 2023

    Report

    Report Number
    3005180920-2023-00286
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 29, 2023
    Report Date
    April 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2109855: 90 ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2021. EXPIRATION DATE: (B)(6) 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 86 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT BATCH REVIEW PERFORMED ON (B)(6) 2023 ON GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT. 2110987 LOT 2110987: 50 ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2021. EXPIRATION DATE: (B)(6) 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO THE LOOSENING OF IMPLANTS CAUSED BY METAL ALLERGY. ALL COMPONENTS REVISED. THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937239 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1202R 2109855 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention